A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Friday, 30 November 2012

Luxembourg: home to the Court of Justiceand place where AGs sometimes get it right ...

Yesterday the IPKat weblog postedthis item on the retirement of Verica Trstenjak as an Advocate General of the Court of Justice of the European Union. A correspondent, who has prudently asked not to be identified adds:

"Verica is is the AG who caused all the confusion over “one SPC per patent” and “subject matter of the invention” in Medeva. If she is off the scene, then perhaps these ideas will have fewer supporters in the referrals on these points in Actavis v Sanofi, Lilly v HGS etc. Credit where credit is due, though - she got Neurim absolutely right!"

Recently, the Pharmaceutical Patents Review Panel released a Background and Suggested Issues Paper in regard to patent extension of term provisions. We are aware that your blog has contained posts relating to pharmaceutical patents in the past and thought you may be interested in the issues under review and the views posted on the Pharmaceutical Patents Review blog.

The Pharmaceutical Patents Review blog can be accessed at the below link:

Thursday, 22 November 2012

Just over a month ago, in "Australia takes aim at SPCs: will they survive?", here, The SPC Blog announced the no-holds-barred review of pharmaceutical patents which was about to take place in Australia. IP Australia has now issued the following information:

Pharmaceutical
Patents Review Panel releases Issues Paper

The Pharmaceutical Patents Review
Panel has released an Issues Paper, inviting the public to make submissions by
21 January 2013. The Panel conducting the review will submit a final
report to Government in April 2013.

The review will evaluate whether the system for pharmaceutical patents is
effectively balancing the objectives of securing timely access to competitively
priced pharmaceuticals, while fostering innovation and supporting research. In
particular, the extension of term provisions will be reviewed.

The public are also invited to contribute to the review by commenting on the
review's blog. The Review Panel will be posting topics
and papers on the blog for further discussion during the review.

This blogger is not certain how inclusively the word "public" is understood within the context of the review, but suspects that its intention is to encourage a wide range of responses rather than merely those from the various sectors of the pharma industry.

The SPC Blog thanks Anna Feros (Shepherd and Wedderburn LLP) for the link.

Monday, 12 November 2012

A few weeks ago The SPC Blog postedthis item on Actavis Group PTC EHF & another v Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat), another case in which the Patents Court, England and Wales, decided to make a reference to the Court of Justice for a preliminary ruling.

The reference is now Case C-443/12 and the two questions posed are confirmed as being as follows:

"1. What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation 469/2009/EC ("the Regulation")?

2. In a situation in which multiple products are protected by a basic patent in force, does the Regulation, and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?"

If you would like to send a comment to the UK Intellectual Property Office on this case, which might result in the UK making representations to the court, please emailpolicy@ipo.gsi.gov.uk by 16 November 2012.

Sunday, 11 November 2012

The SPC Blog is again in debt to the kindness of our very good friend Micaela Modiano (Modiano & Partners) for the following information and insight from Italy with regard to patent linkage:

"Only very recently, the Italian Parliament had abolished
a provision contained in the Italian IP Code and corresponding to a form of
patent linkage. This provision indicated that an application for a
generic marketing authorization could be filed only within the last year of
life of the patent or SPC protecting the originator product, also taking into account any paediatric extension filed with respect to the SPC. The abolition of this
provision followed from an infringement procedure started by the EU
Commission against Italy.

Now, on 8 November 2012, the Italian Parliament has
passed a law entitled "Urgent measures for promoting the development of
the [Italian] State by way of a higher
level of health protection". Among other things, this law provides that the Italian Regulatory Authority (Agenzia Italiana del Farmaco, AIFA) shall carry out an
extraordinary review of the national list of authorized pharmaceutical
products, so as to more clearly identify any therapeutically obsolete medicinal
products.

When carrying out such extraordinary revision, and on the
occasion of any subsequent revision of the national list of authorized
pharmaceutical products, Art. 11(1) of the new law provides that [per Micaela's English
translation]:

"the medicinal products which are equivalent,
according to the law, to medicinal products whose patent or SPCs is yet to
expire/about to expire [translator's note: the Italian terms of the law are not
clear on this point!] cannot be classified as reimbursed by the Italian national
health service prior to the patent or SPC expiry date published by the Ministry
of Economic Development [translator's note: this is the Ministry encompassing
the Italian PTO] according to the provisions of law."

The new law therefore does not appear to introduce a
patent linkage regarding when a generic marketing authorization should be filed
or when it should be granted; nevertheless, the language of Art. 11(1) appears
to introduce a patent linkage regarding when a generic product can be
reimbursed by the national health service.

While the law was under discussion at the Italian
Parliament, the Italian Antitrust Authority had sent a formal communication to
the Parliament proposing that the provision of Art. 11(1) be abolished given
that, in the Authority's own words, such provision "introduces ... a clear
form of 'patent linkage'". Despite this comment by the Authority, the
provision was maintained and is still part of the new law.

The full text of the new law as published in the Italian
OJ of November 8, 2012 can be found here.

Art. 11(1) of the new law should be read and assessed
also in the context of Art. 14 of the current version of the Proposal for a
Directive of the European Parliament and of the Council relating to the transparency of measures
regulating the prices of medicinal products for human use and their inclusion
in the scope of public health insurance systems, which can be found here.

Interestingly enough, Art. 14 is entitled "Non
interference of intellectual property rights...". It will be watching carefully to see how Art. 11(1) of the new Italian law will be reconciled with the
text of Art. 14 of this draft directive.

Surely this will not be the last we hear regarding Italy
and patent linkage!"

Katarzyna Zbierska has kindly drawn our attention to this piece which was published in Special IP issue of the Bulletin of her law firm, Koc...

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